1. Field of Invention
The invention relates to condum drainage devices.
2. Description of Prior Art
Although there have been a number of devices proposed in prior art literature for superceding the condom catheter for effecting external catheter drainage of urine, none has solved the acute problems inherent in this type of device, as hereinafter more fully set forth, and none, to applicant's knowledge, has been successfully used in medical practice. Accordingly, the condom drainage device is the only one currently in general use.
A separate prior art statement is being prepared herein, pursuant to C.F.R. 197 and 198.
The penis is a delicate organ covered by thin epithelium and is particularly susceptible to injury or damage occurring by available means of attachment of the catheter and by inadequate drainage, which expose this epithelium to direct trauma and irritation secondary to urine remaining in contact therewith. These conditions may result in obstruction of venous outflow from the penis, resulting in venous stasis, which may in turn result in increased susceptibility of the epithelium to damage, and even possibly result in the occurrence of venous thrombosis of the penis. Attachment of the catheter over a localized or limited area may result in increased likelihood of direct pressure-induced trauma to the penile epithelium. The exposure of the penis to urine, especially when the urine is infected, frequently results in epithelial injury. As a direct result of such injury to the epithelium, there frequently occurs the problem of contusion of the penis, maceration of the penile epithelium, and actual epithelial infection. In the common condom catheter, the penis is obscured from view, and developing injury and infection may go undetected. The foregoing sequence of events makes continued external catheter drainage impossible and results in two possible and less favorable medical alternatives: allowance of urinary incontinence, with its attendant problems, and resort to internal catheter bladder drainage, which is fraught with serious medical problems.